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Evaluation and Characterization of Sildenafil 50 mg Orodispersible Tablets Using Sublimation Technique

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Last updated: 03 Jan 2025

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Abstract

Objective: The aim of this work focused on formulation and evaluation of sildenafil 50 mg orodispersible tablets by sublimation technique. Methods: Active ingredient and excipients mixtures were evaluated for physicochemical changes of the drug utilizing FTIR spectroscopy and DSC thermal analysis. Nineteen proposed formulae N1-N19 were prepared by sublimation technique using menthol as a sublimating agent. Three different types of superdisintegrants (sodium starch glycolate, croscarmellose sodium and plasidone XL) were used in three different ratios (3, 6 and 9 % w/w), percentage of inter-granular and intragranular disintegrant. Hydrophilic filler such as mannitol and hydrophobic filler such as microcrystalline cellulose were used in the ratio (1:1, 2:1 and 4:1 w/w).Elimination of bitterness using sucralose as a potent sweetener. Granulation was achieved by alcoholic solution of PVP K25 as binder at Diosna® high shear mixer. Lubricant (hydrophobic magnesium stearate and hydrophilic sodium stearyl fumarate). Un-lubricated granules were characterized for bulk density, tapped density, true density, particle size distribution, Carr'sindex, Hausner ratio, flow rate and angle of repose. Tablets were firstly compressed on rotary machine then subjected to vacuum oven at 60ᵒC for 6 hours. Post compression characterization for tablets after sublimation including content uniformity, average weight, hardness, thickness, In-vitro disintegration, friability, wetting time, assay and dissolution profile of the proposed formulae against the immediate release marketed tablet Viagra ® 50 mg tablet. Results: The formula (N 16) which granulated using 1% PVP k25 with 9% plasidone XL (60% of it is inter-granular while 30% intra-granular), menthol 1%, Microcrystalline cellulose: Mannitol 1:1 and magnesium stearate was the most effective formulation as it showed wetting time of 30.7 seconds, disintegration time of 25 seconds and cumulative % drug release of 92.8 and 95.8 % after 1 and 3 minute respectively. Conclusion: Sildenafil 50 mg ODT successfully was prepared by sublimation technique with better wetting time, disintegration time, assay dissolution profile, hardness and friability.

DOI

10.21608/aprh.2018.5126.1065

Keywords

Orodispersibletablets, sildenafil, Superdisintegrant, Sublimation technique, Tablet porosity

Authors

First Name

Ahmed

Last Name

Abbas

MiddleName

-

Affiliation

Department of Research and Development, The Egyptian International Pharmaceutical Industries Co (EIPICO), 10th of Ramadan City, Egypt

Email

dr_ahmed_abbas@yahoo.com

City

Sharkia

Orcid

-

First Name

Wael

Last Name

Ibrahim

MiddleName

-

Affiliation

Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Egypt

Email

wael.ali@eipico.net

City

10th of Ramadan city

Orcid

-

First Name

Wedad

Last Name

Sakran

MiddleName

-

Affiliation

Department of Pharmaceutics, Faculty of Pharmacy Helwan University, Cairo, Egypt

Email

wedadsakran@hotmail.com

City

Cairo,Egypt.

Orcid

0000-0002-4880-8397

First Name

Aliaa

Last Name

Badawi

MiddleName

-

Affiliation

Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Egypt

Email

aliabadawi@yahoo.com

City

Cairo

Orcid

-

Volume

2

Article Issue

4

Related Issue

3784

Issue Date

2018-10-01

Receive Date

2018-09-26

Publish Date

2018-10-01

Page Start

292

Page End

311

Print ISSN

2357-0547

Online ISSN

2357-0539

Article File

APRH_Volume 2_Issue 4_Pages 292-311.pdf

PDF . 886.3kB

Link

https://aprh.journals.ekb.eg/article_18123.html

Detail API

https://aprh.journals.ekb.eg/service?article_code=18123

Order

7

Type

Research Article

Type Code

318

Publication Type

Journal

Publication Title

Journal of Advanced Pharmacy Research

Publication Link

https://aprh.journals.ekb.eg/

MainTitle

Evaluation and Characterization of Sildenafil 50 mg Orodispersible Tablets Using Sublimation Technique

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Article

Created At

22 Jan 2023